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公开(公告)号:US11464828B2
公开(公告)日:2022-10-11
申请号:US16826585
申请日:2020-03-23
Applicant: CSL Limited
Inventor: Yvonne Vucica , Gary Lee Warren
Abstract: The present invention relates to reconstituted high density lipoprotein (rHDL) formulations comprising an apolipoprotein, a lipid and a lyophilization stabilizer. Said formulations have reduced renal toxicity and good long-term stability, especially in lyophilized form.
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公开(公告)号:US10730927B2
公开(公告)日:2020-08-04
申请号:US16041239
申请日:2018-07-20
Applicant: CSL Limited
Inventor: Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC: C07K1/34 , A61K38/00 , C07K14/775
Abstract: A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nm to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-I preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.
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公开(公告)号:US20190015476A1
公开(公告)日:2019-01-17
申请号:US15894397
申请日:2018-02-12
Applicant: CSL Limited
Inventor: Yvonne Vucica , Gary Lee Warren
IPC: A61K38/17 , C07K14/775 , A61K9/00 , A61K9/19
Abstract: The present invention relates to reconstituted high density lipoprotein (rHDL) formulations comprising an apolipoprotein, a lipid and a lyophilization stabilizer. Said formulations have reduced renal toxicity and good long-term stability, especially in lyophilized form.
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公开(公告)号:US10087235B2
公开(公告)日:2018-10-02
申请号:US14910424
申请日:2014-08-08
Applicant: CSL Limited
Inventor: Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC: A61K38/00 , C07K14/775 , C07K1/34
Abstract: A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nrn to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-f preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.
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公开(公告)号:US20210147509A1
公开(公告)日:2021-05-20
申请号:US16945312
申请日:2020-07-31
Applicant: CSL Limited
Inventor: Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC: C07K14/775 , C07K1/34
Abstract: A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nm to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-I preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.
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公开(公告)号:US10421799B2
公开(公告)日:2019-09-24
申请号:US15870203
申请日:2018-01-12
Applicant: CSL LIMITED
Inventor: Yvonne Vucica , Gary Lee Warren
IPC: C07K14/775 , C07K1/30 , A61K38/17 , A61K38/00
Abstract: The present invention relates to processes of obtaining Apo A-1 from an Apo A-1 containing protein fraction (A), comprising suspending the Apo A-1 containing protein fraction (A) in a buffer solution (B), removing impurities from the suspension while keeping the Apo A-1 proteins solubilized, followed by precipitating Apo A˜I from the suspension and collecting the Apo A-1 precipitate. Apo A-I obtained by such processes, reconstituted HDL obtained from such Apo A-1, and pharmaceutical compositions comprising such Apo A-I and/or reconstituted HDL also are provided.
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公开(公告)号:US20180298080A1
公开(公告)日:2018-10-18
申请号:US15870203
申请日:2018-01-12
Applicant: CSL LIMITED
Inventor: Yvonne Vucica , Gary Lee Warren
IPC: C07K14/775 , C07K1/30 , A61K38/00 , A61K38/17
CPC classification number: C07K14/775 , A61K38/00 , A61K38/17 , C07K1/30
Abstract: The present invention relates to processes of obtaining Apo A-I from an Apo A-I containing protein fraction (A), comprising suspending the Apo A-I containing protein fraction (A) in a buffer solution (B), removing impurities from the suspension while keeping the Apo A-I proteins solubilized, followed by precipitating Apo A˜I from the suspension and collecting the Apo A-I precipitate. Apo A-I obtained by such processes, reconstituted HDL obtained from such Apo A-I, and pharmaceutical compositions comprising such Apo A-I and/or reconstituted HDL also are provided.
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公开(公告)号:US09925236B2
公开(公告)日:2018-03-27
申请号:US14439094
申请日:2013-10-31
Applicant: CSL Limited
Inventor: Yvonne Vucica , Gary Lee Warren
IPC: A61K38/17 , A61K9/00 , A61K9/19 , C07K14/775
CPC classification number: A61K38/1709 , A61K9/0019 , A61K9/19 , C07K14/775
Abstract: The present invention relates to reconstituted high density lipoprotein (rHDL) formulations comprising an apolipoprotein, a lipid and a lyophilization stabilizer. Said formulations have reduced renal toxicity and good long-term stability, especially in lyophilized form.
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公开(公告)号:US09890203B2
公开(公告)日:2018-02-13
申请号:US14893178
申请日:2014-06-05
Applicant: CSL LIMITED
Inventor: Yvonne Vucica , Gary Lee Warren
IPC: A61K38/17 , C07K14/775 , C07K1/30 , A61K38/00
CPC classification number: C07K14/775 , A61K38/00 , A61K38/17 , C07K1/30
Abstract: The present invention relates to processes of obtaining Apo A-1 from an Apo A-1 containing protein fraction (A), comprising suspending—the Apo A-1 containing protein fraction (A) in a buffer solution (B), removing impurities from the suspension while keeping the Apo A-1 proteins solubilized, followed by precipitating Apo A˜I from the suspension and collecting the Apo A-1 precipitate. Apo A-I obtained by such processes, reconstituted HDL obtained from such Apo A-1, and pharmaceutical compositions comprising such Apo A-I and/or reconstituted HDL also are provided.
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公开(公告)号:US11732028B2
公开(公告)日:2023-08-22
申请号:US16945312
申请日:2020-07-31
Applicant: CSL Limited
Inventor: Gary Lee Warren , Yvonne Vucica , Christoph Kempf , Martin Stucki
IPC: C07K14/775 , C07K1/34 , A61K38/00
CPC classification number: C07K14/775 , C07K1/34 , A61K38/00
Abstract: A method for purifying Apo A-I is provided including the steps of providing a solution comprising Apo A-I and guanidine hydrochloride and filtering the solution through a filter having a pore size in a range from 15 nm to 35 nm to thereby reduce viral contamination of the Apo A-I. An Apo A-I preparation is provided having at least a 12 log LRV (log reduction value) for a parvovirus; and/or at least 9 log LRV for a non-enveloped virus; and/or at least 8.5 log LRV for a lipid enveloped virus. Also provided are pharmaceutical compositions and reconstituted high density lipoprotein formulation comprising Apo A-I and methods of treating diseases disorders or conditions.
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